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Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Analgesia

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ClinicalTrials.gov Identifier: NCT02898103
Recruitment Status : Completed
First Posted : September 13, 2016
Results First Posted : March 15, 2021
Last Update Posted : April 8, 2021
Sponsor:
Collaborators:
University California Academic Senate
Copenhagen University Hospital at Herlev
SPR Therapeutics
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

Brief Summary:
The moderate-to-severe pain many patients experience following orthopedic surgery is often treated with opioids, which are associated with side effects such as nausea/vomiting, sedation, and respiratory depression (and a risk of abuse). Potent site-specific analgesia with fewer side effects may be provided with a "continuous peripheral nerve block," which involves the percutaneous insertion of a catheter adjacent to the peripheral nerve(s) supplying a surgical site. Local anesthetic is introduced via the catheter. However, there are major problems with continuous nerve blocks that have dramatically limited their use outside academic centers. Percutaneous peripheral nerve stimulation (PNS) or "nerve modulation" is an alternative method of pain control involving the insertion of an electrical lead through an introducing needle-obviating an open surgical incision for placement-followed by the introduction of electric current to produce analgesia. This modality has been used to treat chronic pain, but it has not been evaluated with a randomized, controlled study when applied to acute pain management (post-surgical analgesia). This temporary therapy has multiple theoretical benefits over existing analgesics, such as a lack of systemic side effects (e.g., nausea, respiratory depression), an absence of induced muscle weakness, and a reduced risk of adverse events (e.g. infection). The purpose of the proposed randomized, double-masked, placebo-controlled, crossover, feasibility study is to explore the possibility of treating postoperative pain with ultrasound-guided percutaneous PNS and, if so, to help power a subsequent definitive randomized, controlled trial.

Condition or disease Intervention/treatment Phase
Postoperative Pain Device: Percutaneous peripheral nerve stimulation Device: Sham stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Treatment group assignments were unmasked after the leads were removed 2 weeks after surgery.
Primary Purpose: Treatment
Official Title: Percutaneous Peripheral Nerve Stimulation (Neuromodulation) for Postoperative Analgesia: A Feasibility/Proof-of-Concept Study
Actual Study Start Date : February 24, 2017
Actual Primary Completion Date : July 20, 2018
Actual Study Completion Date : September 20, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Current then Sham then Active Current
Electrical current will be introduced to the insulated percutaneous lead(s) for 5 minutes; then sham/placebo for 5 minutes; and then active electrical current for the following 2-4 weeks
Device: Percutaneous peripheral nerve stimulation
Active electrical stimulation for 5 minutes in the recovery room
Other Names:
  • Percutaneous peripheral neuromodulation
  • Ultrasound-guided percutaneous peripheral nerve stimulation

Device: Sham stimulation
Sham (placebo) stimulation for 5 minutes in the recovery room

Device: Percutaneous peripheral nerve stimulation
Active electrical stimulation for 2-4 weeks at home
Other Names:
  • Percutaneous peripheral neuromodulation
  • Ultrasound-guided percutaneous peripheral nerve stimulation

Active Comparator: Sham then Active Current
Sham/placebo will be introduced to the insulated percutaneous lead(s) for 5 minutes; then active electrical current for the following 2-4 weeks
Device: Percutaneous peripheral nerve stimulation
Active electrical stimulation for 5 minutes in the recovery room
Other Names:
  • Percutaneous peripheral neuromodulation
  • Ultrasound-guided percutaneous peripheral nerve stimulation

Device: Sham stimulation
Sham (placebo) stimulation for 5 minutes in the recovery room

Device: Percutaneous peripheral nerve stimulation
Active electrical stimulation for 2-4 weeks at home
Other Names:
  • Percutaneous peripheral neuromodulation
  • Ultrasound-guided percutaneous peripheral nerve stimulation




Primary Outcome Measures :
  1. Change From Baseline of Surgical Site Pain Level (NRS) at Rest [Percentage of Baseline Pain] [ Time Frame: 5 and 10 minutes after the stimulator is first activated ]
    Pain is evaluated on a Numeric Rating Scale: 0-10 scale with 0=no pain and 10=worst imaginable pain. The outcome measure is calculated as such: the pain score 5 and then 10 minutes after the stimulator is first activated on the Numeric Rating Scale divided by the baseline pain score measured on the same scale. Of note, although this is a crossover design, the order of treatment does influence the effects of each treatment, so the 7 total subjects cannot be grouped together for the active portion and then again for the sham portion--they must remain separate, distinct groups even though this is a crossover design.


Other Outcome Measures:
  1. Percentage of Baseline Muscle Strength [ Time Frame: Two minutes following stimulation initiation following lead insertion ]
    Strength is evaluated using an isometric force electromechanical dynamometer to measure the force produced during a maximum voluntary isometric contraction during plantar flexion. The outcome measure is calculated as such: the force produced after the stimulator is activated divided by the baseline force prior to stimulation initiation. Of note, although this is a crossover design, the order of treatment does influence the effects of each treatment, so the 7 total subjects cannot be grouped together for the active portion and then again for the sham portion--they must remain separate, distinct groups even though this is a crossover design.

  2. Worst Pain at Rest [ Time Frame: Daily for Days 1-14 following surgery, then at 30 and 90 days ]
    Pain level evaluated with a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain. Both treatment groups are receiving active stimulation from 10 minutes following baseline until the leads are removed 2-4 weeks following baseline. However, we do not know if the order of the first 10 minutes of treatment (either sham then stimulation or stimulation then sham) affects subsequent effects. Therefore, these two treatment groups must remain separate for the remainder of the study period (even though both treatment groups are receiving the same intervention on each of the days described here).

  3. Average Pain at Rest [ Time Frame: Daily for days 1-14 following surgery, then at 30 and 90 days ]
    Pain level evaluated with a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain. Both treatment groups are receiving active stimulation from 10 minutes following baseline until the leads are removed 2-4 weeks following baseline. However, we do not know if the order of the first 10 minutes of treatment (either sham then stimulation or stimulation then sham) affects subsequent effects. Therefore, these two treatment groups must remain separate for the remainder of the study period (even though both treatment groups are receiving the same intervention on each of the days described here).

  4. Worst Pain During Movement [ Time Frame: Daily for Days 1-14 following surgery, then at 30 and 90 days ]
    Pain level evaluated with a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain. Both treatment groups are receiving active stimulation from 10 minutes following baseline until the leads are removed 2-4 weeks following baseline. However, we do not know if the order of the first 10 minutes of treatment (either sham then stimulation or stimulation then sham) affects subsequent effects. Therefore, these two treatment groups must remain separate for the remainder of the study period (even though both treatment groups are receiving the same intervention on each of the days described here).

  5. Average Pain During Movement [ Time Frame: Daily for Days 1-14 following surgery, and then at 30 and 90 days ]
    Pain level evaluated with a 0-10 Numeric Rating Scale with 0=no pain and 10=worst imaginable pain. Both treatment groups are receiving active stimulation from 10 minutes following baseline until the leads are removed 2-4 weeks following baseline. However, we do not know if the order of the first 10 minutes of treatment (either sham then stimulation or stimulation then sham) affects subsequent effects. Therefore, these two treatment groups must remain separate for the remainder of the study period (even though both treatment groups are receiving the same intervention on each of the days described here).

  6. Opioid Consumption [ Time Frame: Daily for Days 1-14 following surgery, and then at 30 and 90 days ]
    Oxycodone consumption (oxycodone is a synthetic opioid). Both treatment groups are receiving active stimulation from 10 minutes following baseline until the leads are removed 2-4 weeks following baseline. However, we do not know if the order of the first 10 minutes of treatment (either sham then stimulation or stimulation then sham) affects subsequent effects. Therefore, these two treatment groups must remain separate for the remainder of the study period (even though both treatment groups are receiving the same intervention on each of the days described here).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing orthopedic surgical procedure that frequently results in moderate-to-severe postoperative pain
  • At least 18 years of age
  • Able to understand and willing to take part in study and adhere to all study requirements

Exclusion Criteria:

  • Postoperative analgesic plan includes a single-injection peripheral nerve block in the surgical extremity
  • Chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use > 4 weeks)
  • Known neuro-muscular deficit of the target nerve(s)
  • Anticipated MRI within the following 2 weeks
  • Compromised immune system based on medical history (e.g., immunosuppressive therapies such as chemotherapy, radiation, sepsis, infection), or other conditions that places the subject at increased risk in the opinion of the investigator
  • Implanted spinal cord stimulator, cardiac pacemaker/defibrillator, deep brain stimulator, or other implantable neurostimulator whose stimulus current pathway may overlap
  • History of bleeding disorder
  • Antiplatelet or anticoagulation therapies other than aspirin
  • Allergy to all local anesthetic agents such as lidocaine or previous reaction to anesthesia
  • Allergy to skin-contact materials (occlusive dressings, bandages, tape etc.)
  • Any other condition that may interfere with ability to participate in a clinical trial (e.g., anatomy that may interfere with lead placement) as determined by the Investigators
  • Incarceration
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898103


Locations
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United States, California
UCSD Medical Center, Thornton
La Jolla, California, United States, 92037
Ucsd Ctri
La Jolla, California, United States, 92097
UCSD Medical Center, Hillcrest
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
University California Academic Senate
Copenhagen University Hospital at Herlev
SPR Therapeutics
Investigators
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Principal Investigator: Brian M Ilfeld, MD, MS University California San Diego
  Study Documents (Full-Text)

Documents provided by Brian M. Ilfeld, MD, MS, University of California, San Diego:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brian M. Ilfeld, MD, MS, Professor of Anesthesiology, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02898103    
Other Study ID Numbers: Percutaneous PNS Postop pilot
First Posted: September 13, 2016    Key Record Dates
Results First Posted: March 15, 2021
Last Update Posted: April 8, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations